Endoluminal fluid delivery device and method

Abstract

A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device is connectable to a drug source and includes a dual-lumen catheter, including a treatment device lumen for housing a guidewire and / or a treatment device and a needle lumen for housing a retractable needle. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter.

Description

FIELD OF THE INVENTION[0001]The present invention relates generally to devices and methods for delivering medicinal substances to an area surrounding a hollow tubular structure. More specifically, the invention relates to an improved device and method for delivering fluid to an extravascular space using a needle which pierces through the tubular structure.CROSS-REFERENCE TO RELATED APPLICATION[0002]This application claims priority to U.S. Provisional Application No. 62 / 200,788, filed Aug. 4, 2015, which is incorporated in its entirety herein.BACKGROUND OF THE INVENTION[0003]Normally, valves in veins keep blood moving toward the heart and prevent backflow. In patients with varicose veins, the valves do not function properly, so blood flows back toward the patient's extremities and pools in the veins. This can lead to skin necrosis. Laser or RF ablation treatment creates hypercoagulability to close the abnormal vein, which is subsequently absorbed by the body. The current commonly-use...

AI Technical Summary

Benefits of technology

The patent text describes an improved device for delivering drugs within a patient's body. The device ensures that the needle remains aligned during the procedure, minimizes the number of times the device needs to be replaced, and prevents the device's side holes from being compromised by bodily fluids. The method for using the device also reduces the number of steps required to treat the patient.

Problems solved by technology

In patients with varicose veins, the valves do not function properly, so blood flows back toward the patient's extremities and pools in the veins.

This can lead to skin necrosis.

Disadvantages of this method can include pain for the patient and inefficiency.

The process of delivering tumescent is rather tedious and is far from an exact process.

The process of delivering tumescent fluid prior to a vein ablation procedure is time consuming and cumbersome.

The delivery of tumescent fluid is typically the longest segment of the vein ablation procedure and is often the cause of procedural complications due to the difficulty of precisely locating the needle in the perivenous sheath for multiple sticks.

It is often difficult for the physician to single-handedly administer the fluid because he / she must hold the ultrasound probe with one hand, position the needle with the other while deploying the plunger if a syringe is used.

The physician may advance the needle too far (into the vein or through the far wall of the vein) or not far enough resulting in incomplete fluid delivery and the resultant procedural complications.

Although addressing the problem of multiple injections through a patient's skin, the '165 device fails to solve other problems associated with the varicose vein treatment procedure.

The anatomy of the vein, which may be tortuous, as well as the tendency of the vein to spasm during a procedure, may also cause misalignment of the needle tip within the catheter.

Once misaligned, the user may not be able to manipulate the needle tip back in axial alignment with the designated exit hole, even with ultrasound guidance.

Another difficulty with the device described in the '165 patent is the need for multiple device component exchanges.

Multiple device component exchanges lead to a longer procedure and potential for additional complications.

Yet another drawback of the device and method described in the '165 patent involves the unintended flow of blood, saline and other treatment fluids through side exit holes in the catheter shaft.

The presence of side holes prevents the user from being able to complete this step because saline will flow out of the side holes instead of flowing through the entire catheter and exiting out of the end hole.

Extension of blood within the lumen may result in catheter occlusion.

In addition, withdrawal of the device to the point where a side hole is exposed will result in blood spillage onto the patient and / or treatment area.

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